COBAS® AMPLICOR CT/NG Test 

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
US-IVD
Detection of Chlamydia trachomatis/Neisseria gonorrhoea (CT/NG)
A qualitative in vitro test for the detection of CT and/or NG DNA in urine from males and females*, endocervical swab specimens and male urethral swab specimens†.
 
This test utilizes the polymerase chain reaction (PCR) nucleic acid amplification technique and nucleic acid hybridization for the detection of CT and/or NG in urogenital specimens using the COBAS® AMPLICOR Analyzer.
Features and Benefits
 
This test is based on the four major processes:
  • Specimen preparation
  • PCR amplification of target DNA using target specific complementary biotinylated primers
  • Hybridization of the amplified products to oligonucleotide probes specific to the target(s)
  • Detection of probe-bound amplified products by colorimetric determination
Intended Use
 
The COBAS® AMPLICOR® CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab
specimens as evidence of symptomatic or asymptomatic infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS® AMPLICOR® Analyzer.
 
The COBAS® AMPLICOR® CT/NG Test for Neisseria gonorrhoeae is a qualitative in vitro test for the detection of N. gonorrhoeae DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence of infection with N. gonorrhoeae. N. gonorrhoeae DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS® AMPLICOR® Analyzer.
 
*Not available in the United States for testing female urine specimens for N. gonorrhoeae

†Not available in the United States for testing urethral swab specimens from asymptomatic males for N. gonorrhoeae
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
Contact

Contact your local sales representative for detailed information, questions and ordering.

 

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